CROSS-REFERENCE TO RELATED APPLICATIONThis application claims priority of Taiwanese Application No. 101102196, filed on Jan. 19, 2012.
BACKGROUND OF THE INVENTION1. Field of the Invention
The invention relates to a blood lancing device for pricking a person's skin to obtain a drop of blood.
2. Description of the Related Art
Many medical procedures require a relatively small sample of blood, in the range of 5-50 μl. Normally such a sample is obtained by lancing or piercing the skin at a selected location, such as a finger, to enable collection of 1 or 2 drops of blood. With the advancement of home use tests such as self monitoring of blood glucose, there is a requirement for a simple and safe procedure which can be performed by a person needing such tests.
Lancets in conventional use generally have a rigid body and a sterile pricking element, for example a needle, which protrudes from one end of the rigid body to pierce the skin, thereby enabling the collection of the blood sample. The collected blood is then transferred to a test device or a collection device. Blood is most commonly taken from fingertips, where the supply is generally excellent. However, blood can also be taken from alternate sites, such as earlobes and limbs.
To reduce the anxiety of piercing the skin and to guarantee a reproducible penetration result, many spring-loaded lancing devices have been developed. For example, a lancing device disclosed in European Patent No. 2050393 includes a mode-switch member for switching the lancing device between a cocking state, wherein operation of a loading member provides a cocking of a lancet holder, and a firing state, wherein further operation of the loading member provides an ejection of a lancet placed in the lancet holder.
The abovementioned operations of the loading member need to be done manually. However, the size of such a lancing device is relatively small, so that these manual operations are difficult to be performed on the miniature lancing device.
In another conventional lancing device disclosed in European Patent No. 0668049, before firing, a drive spring is compressed such that a biasing force of the drive spring is sufficient to cause a plunger to strike and drive a lancet into a user's finger. As such, safety can be promoted. However, many manual operations are still required during the lancing process.
In yet another conventional lancing device disclosed in U.S. Pat. No. 4,577,630, a mechanical trigger mechanism can be activated by a contact pressure between the patient's skin and the mechanical trigger mechanism.
In a single-use skin pricking device disclosed in European Patent No. 1247489, a trigger is releasably coupled to a lancet such that movement of the trigger in a first direction moves the lancet in a direction to compress a biasing means, and then causes release of the lancet from the trigger whereby the biasing means drives the lancet in a second direction substantially opposite to the first direction.
In European Patent No. 1755456, a lancet device includes a housing and a lancet structure having a puncturing element. The lancet structure is disposed within the housing and is adapted for movement between a retaining or pre-actuated position where the puncturing element is retained within the housing, and a puncturing position where the puncturing element extends through a forward end of the housing. The lancet device further includes a drive spring disposed within the housing for biasing the lancet structure toward the puncturing position, and a retaining hub retaining the lancet structure in the retaining position against the bias of the drive spring. The retaining hub includes a pivotal lever in interference engagement with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rearward end of the housing to at least partially compress the drive spring, and releasing the lever from interference engagement with the lancet structure. Such a lancet device is disposable after a single use, and thus is suitable for hospital applications. However, it is necessary for a diabetic patient to carry a plurality of the disposable lancet devices, thereby resulting in inconvenience during use.
In skin pricking devices disclosed in WO 2008/009985, WO2010/098531, and European Patent No. 1204372, a spring can be preloaded prior to assembly of the device. However, these devices are al so disposable after a single use, and are operated by manual firing. Hence, it is desirable that a plurality of skin pricking operations can be performed by repeated depressions of the lancing device.
SUMMARY OF THE INVENTIONTherefore, the object of the present invention is to provide a blood lancing device that can perform a plurality of skin pricking operations by repeated presses of the lancing device.
Accordingly, a blood lancing device of the present invention is adapted for pricking a person's skin to obtain a drop of blood and comprises:
a housing unit including a housing body and a positioning portion that is disposed in the housing body, the housing body having a front end section and a rear end section that is opposite to the front end section along an axis;
a cap projecting forwardly from the housing unit, and movable relative to the housing body along the axis between an initial position and a retracted position, the cap having a front end that is disposed outwardly of the housing unit, that is adapted to be in contact with the skin, and that has an opening;
a lancet;
a holder disposed in the housing unit between the cap and the positioning portion of the housing unit, holding the lancet, and movable along the axis relative to the housing unit between a pricking position whereat the lancet extends outwardly from the opening of the cap, and a trigger position whereat the lancet as a whole is disposed in the housing unit;
a first biasing member disposed between the holder and the positioning portion of the housing unit for biasing the holder to move along the axis away from the positioning portion of the housing unit; and
a transmission assembly including a first drive element that is disposed between the cap and the holder and that is driven movably along the axis by the cap, and at least one second drive element that is aligned with the first drive element in the direction of the axis and that is disposed fixedly on the holder such that, when the cap is moved from the initial position toward the retracted position, the second drive element is blocked by the first drive element from forward movement to maintain relative positions of the holder and the first drive element so that the first drive element pushes the holder toward the trigger position and that the second drive element is deviated from the first drive element when the holder reaches the trigger position, thereby allowing for a high speed movement of the holder from the trigger position to the pricking position by virtue of biasing action of the first biasing member.
BRIEF DESCRIPTION OF THE DRAWINGSOther features and advantages of the present invention will become apparent in the following detailed description of the preferred embodiment with reference to the accompanying drawings, of which:
FIG. 1 is a perspective view of a preferred embodiment of a blood lancing device according to the invention, illustrating a cap at an initial position;
FIG. 2 is another perspective view of the preferred embodiment, illustrating the cap at a retracted position;
FIG. 3 is a partly exploded view of the preferred embodiment;
FIG. 4 is an exploded view of the preferred embodiment;
FIG. 5 is a sectional view of the preferred embodiment, illustrating the cap at the initial position and a holder of the preferred embodiment at a pre-actuated position;
FIG. 6 is another sectional view of the preferred embodiment, illustrating the cap at the retracted position and the holder at a cocking position;
FIG. 7 is still another sectional view of the preferred embodiment, illustrating the cap at the retracted position and the holder at a pricking position;
FIG. 8 is an enlarged fragmentary sectional view of the preferred embodiment, illustrating the relation between first and second drive elements of a transmission assembly and a cam surface of a housing unit;
FIG. 9 is another enlarged fragmentary sectional view of the preferred embodiment, illustrating a flexible rod and a pressing lever of a safety switch, and a stop surface of a front end section of the housing unit;
FIG. 10 is still another sectional view of the preferred embodiment, illustrating the relation between a flexible end portion of the holder and an abutment surface of the housing unit at the pre-actuated position;
FIG. 11 is still another sectional view of the preferred embodiment, illustrating the flexible end portion deformed after removal of the front end section of the housing unit so that the holder is blocked from moving rearwardly;
FIG. 12 is a perspective view illustrating the relation between the transmission assembly and the holder of the preferred embodiment;
FIG. 13 is a perspective view illustrating a connection between a sleeve unit and the first drive element of the preferred embodiment;
FIG. 14 is a perspective view illustrating a connection between the sleeve unit and the cap of the preferred embodiment;
FIG. 15 is a perspective view of the cap of the preferred embodiment;
FIG. 16 is yet another sectional view of the preferred embodiment after adjustment of a distance between the cap and the sleeve unit;
FIG. 17 is an exploded perspective view of an end piece and the front end section of the housing unit of the preferred embodiment; and
FIG. 18 is another sectional view of the preferred embodiment, illustrating the cap at the retracted position and the holder at a trigger position
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTAs shown inFIGS. 1,3 and5, a preferred embodiment of ablood lancing device2 according to the present invention is adapted for pricking a person'sskin101 to obtain a drop of blood. Theblood lancing device2 comprises ahousing unit3, acap4 disposed movably on thehousing unit3, alancet10, aholder5 disposed between thehousing unit3 and thecap4 and holding thelancet10, a first biasingmember61 disposed between theholder5 and thehousing unit3, atransmission assembly7 disposed between thecap4 and theholder5, asleeve unit8 disposed between thecap4 and thetransmission assembly7, a pair of angularly spaced-apart adjusting units91 (only one is shown) disposed between thesleeve unit8 and thecap4, asafety switch92 disposed between thehousing unit3 and thesleeve unit8, and asecond biasing member62 disposed between theholder5 and thetransmission assembly7. In this embodiment, the first and second biasingmember61,62 are configured as coil springs, but are not limited to such.
Thehousing unit3 includes ahousing body31 that surrounds an axis (I) and that defines a retainingspace310, and a positioningmember32 that is retained in the retainingspace310. In this embodiment, thehousing body31 is tubular and is easy to be manufactured and to be held by a user. Thehousing body31 has afront end section311 that is adapted to be placed proximate to theskin101 when theblood lancing device2 is in use, and arear end section312 that is opposite to thefront end section311 along the axis (I) and that is adapted to be placed distal from theskin101. The positioningmember32 has inner andouter wall segments321,322 that surround the axis (I). Theinner wall segment321 has apositioning portion323 for abutting against an end of the first biasingmember61. Theouter wall segment322 has a pair of angularly spaced-apart cam surfaces324 that face thecap4. Thehousing body31 andpositioning member32 may be molded as one piece.
Thecap4 projects forwardly from a front end of thehousing unit3, and is movable relative to thehousing body31 along the axis (I) between an initial position (seeFIG. 1) and a retracted position (seeFIG. 2). Thecap4 has a front end wall that is disposed outwardly of thehousing unit3, that is adapted for contact with theskin101, and that has anopening40.
Theholder5 is disposed between thecap4 and thepositioning portion323 of the positioningmember32 of thehousing unit3, and is movable along the axis (I) relative to thehousing unit3 between a pricking position (seeFIG. 7) where aneedle11 of thelancet10 extends outwardly from theopening40 of thecap4, and a trigger position (seeFIG. 18) where thelancet10 as a whole is disposed in thehousing unit3.
Thefirst biasing member61 is disposed between theholder5 and thepositioning portion323 of thehousing unit3 for biasing theholder5 to move along the axis (I) away from thepositioning portion323 of thehousing unit3.
Thetransmission assembly7 includes afirst drive element71 that is connected between thecap4 and theholder5 and that is driven movably along the axis (I) by thecap4, and a pair ofsecond drive elements72 that are aligned with thefirst drive element71 in the direction of the axis (I), that correspond respectively in position to the cam surfaces324 of thehousing unit3, and that are disposed fixedly on theholder5 such that, when thecap4 is moved from the initial position toward the retracted position, thesecond drive elements72 are blocked by thefirst drive element71 from forward movement to maintain relative positions of theholder5 and thefirst drive element71 so that thefirst drive element71 pushes theholder5 toward the trigger position and that thesecond drive elements72 are deviated from thefirst drive element71 when theholder5 reaches the trigger position, thereby allowing for a high speed movement of theholder5 from the trigger position to the pricking position by virtue of biasing action of the first biasingmember61. In this embodiment, thefirst drive element71 and thecap4 are two individual parts. Thefirst drive element71 is tubular, is disposed between thecap4 and theholder5 and is movable in thehousing unit3.
As shown inFIGS. 4,5 and8, each of thesecond drive elements72 has a flexible andelongated rod portion721 extending forwardly from a rear portion of theholder5, and acam block722 disposed on a front free end of therod portion721. Thefirst drive element71 has amain body711 and a pair of limitingsurfaces712 disposed at a rear end of themain body711 and facing respectively the cam surfaces324 of thehousing unit3. Thesecond drive elements72 are configured such that, when thecap4 drives thefirst drive element71 to move from the initial position toward the retracted position, the limitingsurfaces712 of thefirst drive element71 abut respectively against the cam blocks722 of thesecond drive elements72 for preventing the forward movement of thesecond drive elements72 along the axis (I) relative to thefirst drive element71. When thefirst drive element71 pushes thesecond drive elements72 to reach a cocking position (seeFIG. 6), the cam blocks722 of thesecond drive elements72 come into contact with the cam surfaces324. With a further movement of thesecond drive elements72 from the cocking position to the trigger position, thesecond drive elements72 are urged by the cam surfaces324 to deform inwardly and to deviate from the limitingsurfaces712 of thefirst drive element71 so that thesecond drive elements72 and theholder5 prick toward thecap4 along the axis (I) by virtue of the first biasingmember61.
It is noted that theblood lancing device2 of this invention may comprise only onesecond drive element72, one limitingsurface712 on thefirst drive element71 corresponding to the onesecond drive element72, and onecam surface324 on the positioningmember32 of thehousing unit3 corresponding to the onesecond drive element72. Moreover, each of thecam surface324 and the limitingsurface712 may be annular or the like.
As shown inFIGS. 4 and 10, in this embodiment, thefront end section311 and therear end section312 of thehousing body31 are interconnected removably for facilitating the assembly of theblood lancing device2. The positioningmember32 is formed with first and second engagingportions325,326 corresponding respectively to the front andrear end sections311,312. Thefront end section311 has an inner surrounding surface formed with anengaging part314 for engaging removably the first engagingportion325 of the positioningmember32. Therear end section312 has an inner surrounding surface formed with anengaging part315 for engaging the secondengaging portion326 of the positioningmember32. After assembly, each of theholder5, the first biasingmember61, and thefirst drive element71 has a majority retained in therear end section312, while thecap4 is disposed adjacent to thefront end section311. In addition to interconnect the front andrear end sections311,312, the positioningmember32 may be further formed with other structures for facilitating the assembly of other elements.
Referring toFIGS. 7,13 and14, thesleeve unit8 abuts against thefirst drive element71 and is driven by thecap4 to move along the axis (I) relative to thehousing unit3. Theholder5 is retained in and is movable along the axis (I) relative to thesleeve unit8. Thesleeve unit8 includes astopper81 and asleeve body82 respectively proximate to and distal from thecap4. In this embodiment, thesleeve body82 and thestopper81 are formed integrally.
Thestopper81 has afront end wall811 contactable with thelancet10 for preventing further forward movement of thelancet10, and anaperture812 formed through thefront end wall811 and aligned with theopening40 in thecap4 along the axis (I). Thelancet10 includes an insert body held by theholder5 and movable to come into contact with thefront end wall811 of thestopper81 when theholder5 is disposed at the pricking position, and aneedle11 mounted fixedly on a front end of the insert body and extending through theopening40 and theaperture812 when theholder5 is disposed at the pricking position. Thecap4 is movable along the axis (I) relative to thestopper81 to change the distance between thefront end wall811 of thestopper81 and the front end wall of thecap4, thereby adjusting the length of a portion of theneedle11 projecting out of the cap4 (seeFIG. 7 andFIG. 16).
Referring toFIGS. 13,14 and15, the adjustingunits91 are disposed between thestopper81 and thecap4. Each of the adjustingunits91 includes aguide block911 disposed on thestopper81, an inclined spirally-extendingguide slot912 formed in thecap4 and slideably engaged with theguide block911, an engagingtooth914 disposed on an outer surface of thestopper81, and apositioning portion913 having a plurality of circumferentially arranged positioninggrooves915 formed in an inner surface of thecap4. Thecap4 is rotatable relative to thestopper81 and movable along the axis (I) relative to thestopper81 through engagement between theguide block911 and theguide slot912 so as to change the distance between the front end wall of thecap4 and thefront end wall811 of thestopper81. The engagingtooth914 is engagable with a selected one of thepositioning grooves915 to position thecap4 relative to thestopper81. To aid turning thecap4 relative to thestopper81, a restricting structure is formed between thesleeve unit8 and thehousing unit3 such that thesleeve unit8 cannot rotate but can move axially relative to thehousing unit3.
It should be noted that, while this invention is exemplified using a pair of adjustingunits91, only one adjustingunit91 may be employed in other embodiments of this invention.
Referring toFIGS. 1,14 and15, preferably, thehousing unit3 further includes anend piece33 connected to thefront end section311 of thehousing body31 and disposed around thecap4. Each of the adjustingunits91 further includes awindow916 formed in theend piece33, and a plurality ofmarks917 disposed on an outer surface of thecap4 and corresponding respectively to thepositioning grooves915 of the corresponding one of the adjustingunits91 such that rotation of thecap4 relative to theend piece33 results in an individual exposure of themarks917 through thewindow916, thereby indicating an adjusted a length of a portion of theneedle11 of thelancet10 extending outwardly from theopening40 of thecap4 when theholder5 is at the pricking position.
Themarks917 may be configured as symbols or numerals and each of which indicates a respective length of theneedle11 of thelancet10 extending outwardly from theopening40 of thecap4 when theholder5 is at the pricking position. In this embodiment, themarks917 are configured as numerals. As shown inFIGS. 10 and 14, for each adjustingunit91, when theguide block911 is at an end of theguide slot912 proximate to theopening40, the numeral “7” of themarks917 is exposed through thewindow916, and thecap4 is positioned relative to thestopper81 through the engagement between the engagingtooth914 and acorresponding positioning groove915. As such, thefront end wall811 of thestopper81 is at a closest position relative to theopening40 of thecap4, thereby resulting in a maximum length of the portion of theneedle11 projecting out of thecap4 when theholder5 is at the pricking position. On the contrary, when theguide block911 is at another end of theguide slot912 distal from theopening40 and the numeral “1” of themarks917 is exposed through thewindow916, thefront end wall811 of thestopper81 is at a farthest position relative to theopening40 in thecap4, thereby resulting in a minimum length of the portion of theneedle11 projecting out of thecap4 when theholder5 is at the pricking position.
Referring toFIGS. 4,5,9 and17, thesafety switch92 is disposed between theend piece33 of thehousing unit3 and thesleeve body82 of thesleeve unit8, and is operable for preventing an unexpected movement of thecap4 relative to thehousing body31 from the initial position to the retracted position that causes a triggering action of the device. Thefront end section311 of thehousing unit3 has astop surface313 that faces thecap4. Thesafety switch92 includes aflexible rod921 connected to and co-movable with thesleeve body82, and abutting against thestop surface313 so as to prevent movement of thecap4 from the initial position to the retracted position. Thesafety switch92 further includes apressing lever922 disposed on and formed integrally with theend piece33, and a flexible drivenportion923 connected to thefront end section311 and disposed between theflexible rod921 and thepressing lever922. Theflexible rod921 has a rear free end formed with aprojection924 projecting toward the flexible drivenportion923. The flexible drivenportion923 has a rear free end formed with aprojection925 projecting toward theprojection924 of theflexible rod921. Thepressing lever922 is operable to push theflexible rod921 to deviate from thestop surface313 of thefront end section311 via the contact between thepressing lever922 and the flexible drivenportion923 and the contact between theprojection925 of the flexible drivenportion923 and theprojection924 of theflexible rod921, thereby allowing the movement of thecap4 from the initial position to the retracted position. Therefore, an unexpected pricking action may be prevented.
It is noted that, in other embodiments, thesleeve unit8 may be omitted to result in a constant pricking length of theneedle11 of thelancet10 outwardly of thecap4, and theflexible rod921 of thesafety switch92 may hence be connected directly to thecap4 to prevent the unexpected pricking action of the device.
Referring toFIGS. 10,11 and12, the second biasingmember62 is disposed between theholder5 and thefirst drive element71 of thetransmission assembly7 for biasing theholder5 and thefirst drive element71 to move away from each other. To replace thelancet10 after use, thefront end section311 needs to be removed from the positioningmember32, and thesleeve unit8 and thecap4 need to be removed from thefirst drive element71 of thetransmission assembly7. Afterward, thefirst drive element71 is pushed to move to an advanced position (seeFIG. 11) relative to theholder5 by the second biasingmember62.
Preferably, theholder5 has a pair offlexible end portions51 angularly spaced apart from each other and staggered with thesecond drive elements72. Thefirst drive element71 is formed with a pair of receivingholes713 receiving respectively theflexible end portions51 of theholder5. Each of the receivingholes713 is defined by a surface unit that has a restrictingsurface714 facing thecap4. Theinner wall segment321 of the positioningmember32 of thehousing unit3 further has a pair of abutment surfaces327 corresponding to and deviated from theflexible end portions51 of theholder5, respectively. The abutment surfaces327 are positioned such that, when thefront end section311 is removed and thefirst drive element71 is pushed to the advanced position, thefirst drive element71 is biased by the second biasingmember62 to move forward relative to theholder5 and bring theflexible end portions51 to contact respectively the restrictingsurfaces714 of thefirst drive element71. Theflexible end portions51 are consequently urged to deform inwardly and abut respectively against the abutment surfaces327, so that rearward movement of theholder5 relative to therear end section312 of thehousing unit3 is limited. When installing anew lancet10 to theholder5, the applied force toward therear end section312 would not cause an unexpected triggering action of thelancet10 since theholder5 is blocked from moving to the trigger position by the abutment surfaces327. Each of theflexible end portions51 has a restrictingprotrusion511 at a middle thereof for abutting against a respective one of the restrictingsurfaces714 and preventing further forward movement of thefirst drive element71 relative to theholder5 that would otherwise hinder the replacement of theneedle11 or even cause separation of thefirst drive element71 from theholder5 when thefront end section311 is removed.
The operation of theblood lancing device2 to obtain a drop of blood is described in the following. Before use, the length of the portion of theneedle11 extending out of theopening40 of thecap4 may be adjusted via rotation of thecap4.
Referring toFIGS. 5,6 and7, to use theblood lancing device2, the front end of thecap4 is placed on theskin101, and thepressing lever922 is pressed to release thesleeve unit8 from thehousing unit3. At this time, thecap4 is at the initial position and theholder5 is at a pre-actuated position. Afterward, with thehousing unit3 being moved toward theskin101, the cap is pushed from the initial position toward the retracted position, thesleeve unit8 and thefirst drive element71 are driven to move together with thecap4, thesecond drive element72 and theholder5 are pushed by the limitingsurfaces712 of thefirst drive element71 to a cocking position, and the first biasingmember61 is compressed by a backward movement of theholder5. At this time, the cam blocks722 of thesecond drive elements72 contact respectively the cam surfaces324 (seeFIG. 6). With further backward movement of theholder5 relative to thehousing unit3 to the trigger position, thesecond drive elements72 are deviated from the limitingsurfaces712 so that theholder5 is fired to the pricking position by the first biasingmember61 while the second biasingmember62 is compressed (seeFIG. 7), and immediately be drawn to move rearwardly to a post-actuated position by the second biasingmember62 where thecap4 is still at the retracted position and thesecond drive elements72 are retained by thefirst drive element71. Eventually, when theblood lancing device2 is removed from theskin101, due to the restoring force of the second biasingmember62, thecap4 moves back to the initial position, and thefirst drive element71 is driven to move forward relative to theholder5 so that thesecond drive elements72 are not urged by thefirst drive element71, and forward movements of thesecond drive elements72 are limited once again by the limitingsurfaces712 before the next operation of theblood lancing device2.
To sum up, the blood lancing device of this invention has the following advantages:
1. With the configuration of thetransmission assembly7, the first biasingmember61, and the cam surfaces324, theblood lancing device2 could perform a pricking action by simply being placed on and pressed toward theskin101.
2. By virtue of the second biasingmember62, thecap4 can be automatically moved from the retracted position to the initial position while theholder5 can be automatically moved back to the pre-actuated position from the post-actuated position. As a result, the skin pricking operation can be easily repeated.
3. The portion of theneedle11 extending out of theopening40 of thecap4 can be adjusted through the adjustingunits91.
4. By virtue of thesafety switch92, an unexpected pricking action of thelancet10 can be prevented.
5. The positioningmember32 facilitates the interconnection of the front andrear end sections311,312 of thehousing unit3 and the assembling of theblood lancing device2. Moreover, other elements that have various functions may be installed in theblood lancing device2 easily by virtue of the positioningmember32.
While the present invention has been described in connection with what is considered the most practical and preferred embodiment, it is understood that this invention is not limited to the disclosed embodiment but is intended to cover various arrangements included within the spirit and scope of the broadest interpretation so as to encompass all such modifications and equivalent arrangements.